MRI-Guided Prostate Boosts for Prostate Cancer

(BLaStM Trial)

Overseen By Pavel Noa Hechavarria

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Miami

Must be taking: Anti-androgens

Disqualifiers: Metastasis, Previous pelvic radiotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 7.5-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve prostate cancer treatment by using high-dose radiation targeted to high-risk tumor areas identified by MRI, while protecting nearby organs. Researchers are studying two radiation methods: HEIGHT RT and LEAD RT, both forms of stereotactic body radiation therapy, each with a unique schedule. The trial seeks participants with confirmed prostate cancer, no signs of spreading, and no history of pelvic radiation or prostate removal surgery. As an unphased trial, this study offers a unique opportunity to advance prostate cancer treatment strategies.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, if you are on androgen deprivation therapy (ADT), there are specific guidelines you must follow. Please discuss with your doctor for more details.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on androgen deprivation therapy (ADT), there are specific guidelines about its use during the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both HEIGHT RT and LEAD RT therapies are generally well-tolerated by prostate cancer patients. Studies indicate that HEIGHT RT is safe for those with intermediate and high-risk prostate cancer, with patients experiencing good results and few side effects.

Regarding LEAD RT, research supports its use and shows a promising safety record. Some studies mention moderate stomach and digestion problems, as well as sexual side effects, but these are not very common.

Overall, these treatments have demonstrated a good balance of effectiveness and safety, based on the available evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because HEIGHT RT and LEAD RT offer innovative approaches to delivering radiotherapy for prostate cancer. Unlike standard radiotherapy, both treatments use advanced imaging techniques to precisely target cancer cells, potentially minimizing damage to surrounding healthy tissue. HEIGHT RT employs a hypofractionated schedule, meaning higher doses per session over a shorter timeframe, which could enhance efficiency and reduce treatment duration. Meanwhile, LEAD RT involves an extreme ablative dose approach in a lattice pattern, potentially increasing the intensity of the attack on cancer cells while sparing healthy tissue. These techniques could lead to more effective and less invasive treatment options for prostate cancer patients.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research has shown that both HEIGHT RT and LEAD RT, studied in this trial, are promising treatments for prostate cancer. Participants may receive HEIGHT RT, where studies indicate that a high dose of radiation can help prevent cancer recurrence. This method also targets high-risk areas more precisely, reducing harm to nearby healthy tissues.

Alternatively, participants may receive LEAD RT, which uses a precise form of radiation therapy known as stereotactic ablative radiation. This method has proven effective in treating prostate cancer and is known for being convenient and cost-effective. Both treatments in this trial focus on delivering high doses of radiation to the tumor while protecting healthy tissue, helping to maintain quality of life. ^{1 2 3 4 5}

Who Is on the Research Team?

Alan Pollack, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

Men aged 35-85 with confirmed prostate cancer (adenocarcinoma), T1-T3 stage, Gleason score 6-10, and PSA ≤100 ng/mL. No metastasis or previous radical prostate surgery/radiotherapy. Androgen deprivation therapy is allowed if decided before joining. Participants must be able to consent and willing to complete quality of life assessments.

Inclusion Criteria

My prostate cancer has a Gleason score between 6 and 10.

Suspicious peripheral zone or central gland lesion on MP-MRI

My prostate cancer is confirmed by biopsy.

Exclusion Criteria

I have a history of disorders related to lymphocyte proliferation.

I have a history of cancer.

I do not have any active cancer except for non-spreading skin cancer or early chronic lymphocytic leukemia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either HEIGHT or LEAD radiotherapy, consisting of 39 fractions over approximately 7.5 to 8 weeks

7.5-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI-directed biopsy results at 2-2.5 years

Up to 5.25 years

Long-term Monitoring

Participants' health-related quality of life and other outcomes are assessed up to 5.25 years post-treatment

Up to 5.25 years

What Are the Treatments Tested in This Trial?

Interventions

• HEIGHT RT
• LEAD RT

Trial Overview

The study tests adding a high dose radiation treatment targeting MRI-defined high-risk tumor areas in the prostate, on top of standard radiation therapy, aiming to control cancer while sparing nearby organs from excess radiation.

How Is the Trial Designed?

Group I: LEAD RT Group Experimental Treatment 1 Intervention

Participants in this group will receive the Lattice Extreme Ablative Dose (LEAD) radiotherapy. Radiotherapy will begin within two months of fiducial marker placement. The therapy will consist of 39 fractions over approximately 8 weeks.

Group II: HEIGHT RT Group Experimental Treatment 1 Intervention

Participants in this group will receive the Hypofractionated Extended Image-Guided Highly Targeted (HEIGHT) radiotherapy. Radiotherapy will begin within two months of fiducial marker placement. The therapy will consist of 39 fractions over approximately 7 and a half weeks.

HEIGHT RT is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer

Approved in United States as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer

Approved in Canada as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

In a phase 3 randomized clinical trial involving 156 men with localized prostate cancer, MRI-guided stereotactic body radiotherapy (SBRT) significantly reduced the incidence of acute grade 2 or greater genitourinary toxic effects compared to CT guidance (24.4% vs 43.4%; P=0.01).

MRI guidance also led to fewer gastrointestinal toxic effects and better patient-reported outcomes, with a lower percentage of patients experiencing significant increases in urinary symptoms and decreases in bowel quality of life scores at 1 month post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging-Guided vs Computed Tomography-Guided Stereotactic Body Radiotherapy for Prostate Cancer: The MIRAGE Randomized Clinical Trial. Kishan, AU., Ma, TM., Lamb, JM., et al.[2023]

In a comparison of two treatment methods for high-risk prostate cancer, the SABR boost showed a significantly lower rate of biochemical failure (0%) compared to the HDR-BT boost (18.2%) over a median follow-up of 62 to 72 months, suggesting better efficacy for SABR.

Both treatment methods resulted in similar levels of acute and late toxicity, with minimal impact on quality of life, indicating that SABR may be a safe alternative to HDR-BT for patients undergoing pelvic radiation therapy and androgen deprivation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gantry-Based 5-Fraction Elective Nodal Irradiation in Unfavorable-Risk Prostate Cancer: Outcomes From 2 Prospective Studies Comparing SABR Boost With MR Dose-Painted HDR Brachytherapy Boost. Musunuru, HB., Cheung, P., Vesprini, D., et al.[2022]

In a study of 84 low-risk prostate cancer patients treated with Stereotactic Ablative Body Radiotherapy (SABR), long-term quality of life (QOL) outcomes were generally positive, with a median follow-up of 50.8 months, although some patients reported declines in urinary (17.9%), bowel (26.2%), and sexual (37.5%) QOL domains.

Dosimetric factors such as rectal D1cc and penile bulb V35 were identified as significant predictors of worse QOL, highlighting the importance of adhering to strict dosimetric constraints to minimize side effects from treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. Elias, E., Helou, J., Zhang, L., et al.[2018]

In a study of 51 localized prostate cancer patients treated with 1.5T MRgSBRT, the treatment demonstrated low rates of acute and subacute toxicities, with only 11.8% experiencing grade ≥ 2 acute genitourinary (GU) toxicities and 2.0% experiencing grade ≥ 2 acute gastrointestinal (GI) toxicities.

Patient-reported outcomes showed that while urinary, bowel, and hormonal scores decreased initially after treatment, they mostly returned to baseline levels over time, indicating that MRgSBRT is a safe option with manageable side effects for prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

1.5T Magnetic Resonance-Guided Stereotactic Body Radiotherapy for Localized Prostate Cancer: Preliminary Clinical Results of Clinician- and Patient-Reported Outcomes. Poon, DMC., Yuan, J., Wong, OL., et al.[2021]

In a study of 66 prostate cancer patients treated with ultra-hypofractionated stereotactic body radiation therapy (SBRT), the treatment demonstrated excellent biochemical control, with a 2-year freedom from biochemical failure (FFBF) rate of 88.4%.

The treatment was associated with low toxicity, as no patients experienced severe (grade ≥3) genitourinary toxicity, and only 13.6% experienced grade 2 toxicities, indicating that SBRT is a safe option for postoperative prostate cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment outcomes of postoperative ultra-hypofractionated stereotactic body radiotherapy in prostate cancer. Ozyigit, G., Onal, C., Beduk Esen, CS., et al.[2023]

Stereotactic ablative radiation (SAbR) at a dose of 45 Gy in 5 fractions shows a promising safety profile for treating localized prostate cancer, with acute urinary and gastrointestinal toxicity rates of 20.4% and 7.3%, respectively, and low rates of late toxicity after 2 years.

The treatment demonstrated excellent efficacy, with a biochemical failure-free survival rate of 100% at 1 year and 98.7% at 2 years, indicating strong disease control outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. Chen, L., Gannavarapu, BS., Desai, NB., et al.[2022]

Stereotactic ablative radiotherapy (SABR) has been shown to be feasible and well tolerated for low- and intermediate-risk prostate cancer patients, with promising results from large randomized studies comparing it to conventional treatments.

While SABR shows potential benefits and cost-effectiveness, there is currently insufficient data to recommend its use for high-risk prostate cancer patients outside of clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Body Radiotherapy for Intermediate- or High-Risk Prostate Cancer. Loblaw, A.[2021]

In a study involving 20 prostate cancer patients treated with Adaptive Stereotactic Body Radiotherapy (SBRT), the delivered dose was confirmed to be adequate, ensuring that the target area received at least 95% of the prescribed dose while minimizing exposure to surrounding organs.

The study demonstrated that both the daily re-computed doses and cumulative doses were consistent, indicating that the online MRI guidance effectively maintained treatment accuracy despite potential prostate motion during the longer session times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive SBRT by 1.5 T MR-linac for prostate cancer: On the accuracy of dose delivery in view of the prolonged session time. Ruggieri, R., Rigo, M., Naccarato, S., et al.[2021]

CyberKnife stereotactic ablative radiotherapy (SABR) for treating intermediate- to very-high-risk prostate cancer showed a high 3-year biochemical relapse-free survival rate of 90.2%, indicating its efficacy in managing this condition.

The treatment was well-tolerated, with no patients experiencing severe toxicity (≥ grade 3), and only mild genitourinary and gastrointestinal side effects were reported, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. Fan, CY., Chao, HL., Huang, WY., et al.[2017]

Stereotactic ablative body radiotherapy (SABR) is an advanced treatment that delivers high doses of radiation in fewer sessions while protecting surrounding healthy tissues, making it effective for small tumors in various locations, including the prostate.

SABR is becoming a standard treatment for low and intermediate-risk prostate cancer, supported by research from Sunnybrook and the US prostate SABR consortium, highlighting its efficacy in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of hypofractionated accelerated radiotherapy for prostate cancer - the sunnybrook experience. Musunuru, HB., Cheung, P., Loblaw, A.[2022]

In a study of 200 prostate cancer patients treated with MR-guided stereotactic body radiotherapy (SBRT), the treatment demonstrated low acute toxicity, with the most common side effect being mild urinary issues in 31% of patients.

The therapy resulted in a significant decrease in Prostate Specific Antigen (PSA) levels in 99% of patients, indicating effective treatment outcomes, while real-time MRI monitoring ensured precise targeting during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of the first 200 patients with prostate cancer treated with MRI-Linac at Assuta MC. Gelbart Pridan, O., Ben David, MA., Zalmanov, S., et al.[2023]

Stereotactic ablative body radiation (SABR) is a promising non-invasive treatment for localized prostate cancer, showing similar efficacy to brachytherapy in terms of disease control and lower side effects, making it a potentially safer option.

SABR is also more cost-effective and resource-efficient compared to traditional radiation techniques, but further well-powered studies are needed to confirm its benefits before it can be considered standard care, especially for patients with metastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy in patients with prostate cancer. Loblaw, A., Liu, S., Cheung, P.[2023]

In a study of 50 prostate cancer patients treated with MRI-guided adaptive radiotherapy (MRgRT) using ultra-hypofractionation, the treatment was well tolerated, with manageable acute genitourinary toxicity rates of 28% for Grade 1 and 36% for Grade 2, and very low gastrointestinal toxicity.

MRgRT allows for real-time tracking and adaptive planning during stereotactic body radiotherapy (SBRT), suggesting it is a promising method for delivering effective treatment with an acceptable safety profile for localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance image-guided adaptive stereotactic body radiotherapy for prostate cancer: preliminary results of outcome and toxicity. Ugurluer, G., Atalar, B., Zoto Mustafayev, T., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4721063/

Outcomes of hypofractionated stereotactic body ...

Treatment of intermediate and high-risk prostate cancer with a high BED has been shown to increase recurrence free survival (RFS).

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6558188/

Hypofractionated Image-Guided Radiation Therapy With ...

Conclusion: Targeting areas at high-risk for occult disease with a lower radiation dose, while simultaneously boosting gross disease with HIGRT in patients with ...

3.

practicalradonc.org

practicalradonc.org/article/S1879-8500(23)00237-0/fulltext

Stereotactic Body Radiation Therapy: A Radiosurgery ...

External beam radiation therapy (RT) is a safe and effective curative treatment modality for men with localized prostate cancer (PCa). While ...

4.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/1533033818789633

Stereotactic Body Radiotherapy for Primary Prostate Cancer

This review will outline the efficacy and toxicity outcomes of SBRT and highlight specific issues and controversies surrounding patient ...

5.

researchgate.net

researchgate.net/publication/356142014_Stereotactic_Ablative_Radiotherapy_for_High-Risk_Prostate_Cancer-a_Prospective_Multi-level_MRI-based_Dose_Escalation_Trial

Stereotactic Ablative Radiotherapy for High-Risk Prostate ...

Purpose Radiation dose intensification improves outcome in men with high-risk prostate cancer (HR-PCa). A prospective trial was conducted to ...